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Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis

Primary Purpose

Proteinuria, Focal Segmental Glomerulosclerosis

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

tripterygium wilfordii (TW)

About this trial

This is an interventional treatment trial for Proteinuria focused on measuring Focal Segmental Glomerulosclerosis, Prednisone, Tripterygium Wilfordii

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-60 years at onset of signs or symptoms of FSGS
Urine protein ≥ 3.5 g/24 h
Estimated glomerular filtration rate (GFR) ≥ 40 ml/min/1.73 m2, serum creatinine<2.5mg/dl
Biopsy confirmed as idiopathic FSGS (including all subtypes)
Willingness to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures

Exclusion Criteria:

Secondary FSGS
Prior therapy with sirolimus, Cyclosporine, MMF, azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
Active/serious infection
Malignancy
Previously diagnosed as diabetes mellitus type 1 or 2, or abnormal carbohydrate tolerance
Peripheral white blood cells < 3000/ul
Clinical evidence of cirrhosis or chronic active liver diseases
History of significant gastrointestinal disorder
Allergy to study medications, and Inability to consent/assent

Sites / Locations

Research Institute of Nephrology, Jinling Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Large pred

small pred

Arm Description

Prednisone 60mg/d*8 wks

Pred 30mg/d*8wks

Outcomes

Primary Outcome Measures

To assess the efficacy and safety of TW in the treatment of FSGS

Secondary Outcome Measures

Full Information

NCT ID

NCT00801463

First Posted

December 2, 2008

Last Updated

May 17, 2011

Sponsor

Nanjing University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00801463

Brief Title

Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis

Official Title

Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to assess the efficacy of prednisone and tripterygium wilfordii in treated Focal Segmental Glomerulosclerosis (FSGS).

Detailed Description

Primary FSGS is a leading cause of end stage renal disease in adults, with complete loss of kidney function in 50% of patients over 10 years. Steroids, which are currently used to treat the disease, are effective in part of patients. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with high-dose and over 6mo prednisone in patients with FSGS. These studies show that the total effective rates were only around 50%. But this therapy had taken some side effects of prednisone. Except these studies, in recent studies suggest that Tripterygium Wilfordii may be effective for passive Heymann nephritis, podocyte injury in nephrosis rats induced y puromycin aminonucleoside, and so on. FSGS is a podocytepathy. There was no-data of Prednisone and Tripterygium Wilfordii treatment of Chinese adult patients with idiopathic FSGS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proteinuria, Focal Segmental Glomerulosclerosis

Keywords

Focal Segmental Glomerulosclerosis, Prednisone, Tripterygium Wilfordii

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Large pred

Arm Type

Experimental

Arm Description

Prednisone 60mg/d*8 wks

Arm Title

small pred

Arm Type

Experimental

Arm Description

Pred 30mg/d*8wks

Intervention Type

Drug

Intervention Name(s)

tripterygium wilfordii (TW)

Other Intervention Name(s)

tripterygium wilfordii

Intervention Description

Pre 30mg/d +TW 120 mg/d, po for 12 weeks

Primary Outcome Measure Information:

Title

To assess the efficacy and safety of TW in the treatment of FSGS

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-60 years at onset of signs or symptoms of FSGS Urine protein ≥ 3.5 g/24 h Estimated glomerular filtration rate (GFR) ≥ 40 ml/min/1.73 m2, serum creatinine<2.5mg/dl Biopsy confirmed as idiopathic FSGS (including all subtypes) Willingness to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures Exclusion Criteria: Secondary FSGS Prior therapy with sirolimus, Cyclosporine, MMF, azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days Active/serious infection Malignancy Previously diagnosed as diabetes mellitus type 1 or 2, or abnormal carbohydrate tolerance Peripheral white blood cells < 3000/ul Clinical evidence of cirrhosis or chronic active liver diseases History of significant gastrointestinal disorder Allergy to study medications, and Inability to consent/assent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhi-hong Liu, M.D

Organizational Affiliation

Research Institute of Nephrology, Jinling Hospital,

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Institute of Nephrology, Jinling Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

35224732

Citation

Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.

Results Reference

derived

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Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis

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